Kornimate/medical-research-clean huggingface dataset:
safety of new formulation of glatiramer acetate

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of glatiramer acetate (ga) versus investigational formulation of ga. in addition, the investigators will evaluate the side effects of the two formulations of ga.


Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age with a diagnosis of rrms * currently injecting ga 20mg/1.0ml per day subcutaneously (sc) for a minimum of 90 days utilizing the autoject®2 for glass syringe or by a manual injection technique * willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study * willing and able to be trained on a seven site injection rotation. subject must be willing to comply with a minimum five injection site rotation plan during the study * willing and able to complete all procedures and evaluations related to the study * willing to continue to follow usual injection site preparation and routine adjunctive lisr management techniques * willing and able to provide written informed consent exclusion criteria: * currently using or treated with another immunomodulating therapy (imt) in conjunction with ga in the 30 days prior to screening for this study * currently using intermittent or pulse courses of corticosteroids by any route of administration in the 30 days prior to screening for this study. (corticosteroids are prohibited for the duration of the study.) * currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study * presence or history of skin necrosis * known extensive dermatological condition that could be a confounding factor * pregnant or planning pregnancy or breastfeeding * any physical condition that impairs ability to be injected at the minimum of five sites rotation * not able or willing to complete a daily diary * use of any other parenteral medications (e.g., intramuscular, sc, intravenous, etc.) either currently or in the past 30 days prior to screening for this study * any other medical or psychiatric conditions that would make the subject unsuitable for this research, as determined by the investigator * previous participation in this study

Keywords: multiple sclerosis relapsing remitting multiple sclerosis (rrms) glatiramer acetate (ga)
sensory stimulation in fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.

the trial will last up to 8 weeks for each subject and includes: three weeks treatment 1 (sham or actual) two week washout three weeks treatment 2 (sham or actual) vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.

Eligibility criteria:
inclusion criteria: * a diagnosis of fibromyalgia according to the american college of rheumatology (acr) (arthritis rheum, 1990;33:160-172) * clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion) * diagnoses established by an expert on fibromyalgia. * stable treatment of chronic use. * subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent. exclusion criteria: * generalized inflammatory articular or rheumatic disease. * heavily exercise for 12 hours prior to fmri assessment * severe, non-stable medical, endocrinological or neurological disorder. * psychotic disorder or drug abuse.
evaluation of two therapies for the treatment of osteoarticular inflammation in dyspeptic patients

Conditions: Acute and Chronic Inflammation; Dyspepsia

Summary: the purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.

* double-blind,randomized, multicenter * experiment duration: 14 days * 03 visits * evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to association with one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation * adverse events evaluation

Eligibility criteria:
inclusion criteria: * adults male or female aged ≥ 18 years old; * comply with all the purposes and procedures of the study by signing and dating the informed consent. * acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days. exclusion criteria: * pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period * history of peptic ulcer or gastric surgery; * use of non-steroidal anti-inflammatory (nsaids), aspirin, proton pump inhibitor (ppis), h2 blocker and antacid in the past 7 days; * contraindication to the use of nsaids or ppis; * renal or hepatic impairment;
study to evaluate the efficacy and safety of remdesivir (gs-5734™) treatment of coronavirus disease 2019 (covid-19) in an outpatient setting

Conditions: COVID-19

Summary: the primary objectives of this study are to evaluate the efficacy of remdesivir (rdv) in reducing the rate of of coronavirus disease 2019 (covid-19) related hospitalization or all-cause death in non-hospitalized participants with early stage covid-19 and to evaluate the safety of rdv administered in an outpatient setting.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and \< 18 years of age) prior to performing study procedures. individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (irb) or independent ethics committee (iec). for individuals ≥ 12 and \< 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures * either: * age ≥ 18 years (at all sites) or aged ≥ 12 and \< 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant irb or iec with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease) * or aged ≥ 60 years * severe acute respiratory syndrome (sars)-coronavirus (cov)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (pcr) or antigen testing) ≤ 4 days prior to screening * presence of ≥ 1 symptom(s) consistent with covid-19 for ≤ 7 days prior to randomization * not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care) key exclusion criteria: * participation in any other clinical trial of an experimental treatment and prevention for covid-19 * prior hospitalization for covid-19 * treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 or administration of any sars-cov-2 (or covid-19) vaccine * requiring oxygen supplementation note: other protocol defined inclusion/exclusion criteria may apply.
metronidazole and amoxicillin for the treatment of type 2 diabetic subjects with periodontitis

Conditions: Periodontitis

Summary: diabetes mellitus (dm) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. the use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (srp) in diabetic subjects. the combination of metronidazole (mtz) and amoxicillin (amx) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of srp in the treatment of with chronic periodontitis (chp). however, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. therefore, the aim of this randomized clinical trial (rct) will be to evaluate the clinical and microbiological effects of the use of mtz+amx as adjuncts to srp for the treatment of type 2 diabetic subjects with generalized chp.


Eligibility criteria:
inclusion criteria: * ≥ 35 years of age * diagnosis of type 2 dm for ≥ 5 years * dm treatment with diet and insulin supplementation or oral hypoglycemic agents * glycated hemoglobin (hba1c) levels ≥ 6.5% ≤ 11% * at least 15 teeth * more than 30% of the sites with probing depth (pd) and clinical attachment level (cal) ≥ 4 mm * minimum of six teeth with at least one site with pd and cal ≥ 5 mm and bleeding on probing (bop) at baseline. exclusion criteria: * pregnancy * lactation * current smoking * smoking within the past 5 years * scaling and root planing (srp) in the previous 12 months * antimicrobial therapies during the previous 6 months * medical conditions requiring prophylactic antibiotic coverage * continuous use of mouthrinses containing antimicrobials in the preceding 3 months * systemic conditions (except dm) that could affect the progression of periodontitis (e.g. immunological disorders, osteoporosis) * long-term administration of anti-inflammatory * long-term administration of immunosuppressive medications * allergy to metronidazole and/or amoxicillin * presence of periapical pathology * use of orthodontic appliances * presence of extensive prosthetic rehabilitation * major complications of dm (i.e. cardiovascular and peripheral vascular diseases \[ulcers, gangrene and amputation\], neuropathy and nephropathy)

Keywords: periodontitis diabetes
patient-driven transfusion thresholds in hematological disorders: a pilot study

Conditions: Anemia; Aplastic Anemia; Bone Marrow Failure; Hematopoietic and Lymphoid Cell Neoplasm; Leukemia; Myelodysplastic Syndrome

Summary: this pilot study evaluates safety of administration of red blood cell transfusions requested by patients based on their symptoms instead of levels of hemoglobin for the treatment of chronic anemia in patients with blood disorders.

primary objective: i. to assess feasibility and safety of red blood cell transfusions at the time subjects requested based on symptomatic anemia. secondary objectives: i. to define a patient-driven red blood cell transfusion (rbct) threshold and to compare the median hemoglobin (hgb) at the time subjects request rbct to the standard threshold of hgb \< 8 g/dl. ii. to compare the number of red blood cell (rbc) units transfused and the frequency of transfusions at the time subjects request rbct during the study period to the number of rbc units received and frequency using the standard threshold hemoglobin \< 8 g/dl during a comparable period prior to enrollment. iii. to compare the quality of life (qol) scores when subjects request rbct to the scores obtained at the time hgb is 8 +/- 0.5 g/dl. outline: patients undergo rbct based on their perception and/or the presence of anemia symptoms for up to 6 months. after completion of study treatment, patients are followed up for 30 days.

Eligibility criteria:
inclusion criteria: * diagnosed with hematological malignancy or marrow failure syndrome such as but not limited to: aplastic anemia, myelodysplastic syndrome or leukemia * chronic transfusion-dependent anemia with exposure to at least 5 rbct * interested in reducing transfusion exposure * willing to sign informed consent exclusion criteria: * recent acute bleeding requiring intervention in less than 24 hours * hemoglobin levels \< 6 g/dl * acute leukemia receiving induction chemotherapy * any patient with known ischemic heart disease, history of congestive heart failure, history of stroke, or cardiac arrhythmia for which the patient requires medication or a medical device * oxygen dependent * oxygen saturation below 92% on room air * receiving erythropoietin stimulating agent * thalassemia major or sickle cell disease requiring blood transfusion * undergoing major surgery * hemolytic anemia * coagulopathies including disseminated intravascular coagulation (dic), receiving anticoagulant or antiplatelet agents * diagnosed with chronic obstructive pulmonary disease (copd) oxygen dependent * pregnancy * participation in a therapeutic clinical trial
development of countermeasures against adverse metabolic effects of shift work

Conditions: Circadian Dysregulation

Summary: the goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.

shift work is associated with circadian misalignment and an increased risk for the development diabetes, obesity, and cardiovascular disease. this research will determine whether changing the feeding schedule can prevent metabolic alterations that can lead to the abovementioned disorders. this research will provide mechanistic insight and may provide a novel therapeutic approach against the increased risk for diabetes, obesity, and cardiovascular disease among shift workers.

Eligibility criteria:
inclusion criteria: * bmi between 18.5 and 29.9 kgm-2 * healthy adults with regular sleep-wake timing * non-smokers * completion of medical and psychological screening tests * able to spend 14 consecutive days in the sleep laboratory exclusion criteria: * bmi \ 29.9 kgm-2 * history of neurological or psychiatric disorder * history of sleep disorder or regular use of sleep-promoting medication * current prescription, herbal, or over-the-counter medication use * traveling across 2 or more time zones within past 3 months * donating blood within past 8 weeks * worked night or rotating shift work within past 3 years * hearing impairment * drug or alcohol dependency

Keywords: circadian misalignment, forced desynchrony, metabolism, meal-timing, circadian
effects of afq056 and nicotine in reducing cigarette smoking

Conditions: Smoking Abstinence

Summary: the purpose of this study is to assess the safety and efficacy of afq056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. this study will also assess how the body interacts with afq056.


Eligibility criteria:
inclusion criteria: * healthy, male \& female subjects at least 18 years and ≤60 years of age * in good health * female subjects must be surgically sterilized or postmenopausal. * current smokers not intending to quit * smoke on average 15 cigarettes or more and less than 60 cigarettes a day for the past year * fagerström test for nicotine dependence score of at least 5 (indicates moderate to heavy smokers) * willing to refrain from smoking as required * written informed consent before entering the study exclusion criteria: * history of heart disease, septum defect and/or cardiac valves surgery; clinical relevant abnormality in the ecg * investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period * women of childbearing potential, pregnant or lactating females * donation of one unit (400ml) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 months or a blood transfusion within 8 weeks prior to screening. * coffee consumption of more than 6 cups coffee/day * use of a medication within 2 weeks prior to day 1 of each treatment period other protocol-defined inclusion/exclusion criteria may apply

Keywords: smoking, abstinence, craving, smoker, afq056, nicotine, placebo
effect of metabolic dysfunction in branched-chain amino acids on cardiac function in patients with sepsis

Conditions: Sepsis

Summary: the current project was designed to examine the effects of bcaa metabolic dysfunction on cardiac function in septic patients.

patients with sepsis and with/without type 2 diabetes will be included. patients prospectively collected the following indicators in the intensive care unit: 1. myocardial injury-related biomarkers: troponin t and b natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: troponin t\>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. additionally, the investigators will collect the peripheral blood at preoperative, day 1, day 3, and day 5 after surgery. peripheral blood plasma and pbmcs were separated by differential centrifugation: the concentration of bcaas in serum and pbmcs; the expression of pbmcs bcaas metabolic enzymes bcat 1, bckdh, and pp 2 cm by wb; and the levels of ast, alt, ldh, ck, and ck-mb

Eligibility criteria:
inclusion criteria: - patients diagnosed with sepsis with or without type 2 diabetes exclusion criteria: - patients with immunodeficient diseases patients who accept glucocorticoid or immunosuppressant patients with an age younger than 18 years patients who cannot provide informed consent
apatinib in the treatment of metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this is an exploratory clinical trial study on apatinib in the treatment of metastatic colorectal cancer who have progressed after standard second line therapy.


Eligibility criteria:
inclusion criteria: * ≥ 18 and ≤ 80 years of age * histological confirmed advanced or metastatic colorectal cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral ct * have failed for ≥ 2 lines of chemotherapy and/or targeted therapy * life expectancy of more than 3 months * ecog performance scale 0～1 * duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents * adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 ×10\^9/l, neutrophil \> 1.5 × 10\^9/l, serum creatinine ≤ 1×upper limit of normal(uln), bilirubin \< 1.5 uln, and serum transaminase ≤ 2.0× uln) * child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. male: all subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. * signed and dated informed consent. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. exclusion criteria: * prior vegfr inhibitor treatment within 2 weeks * history of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * preexisting uncontrolled hypertension defined as more than 140/90 mmhg despite using single medical therapy * more than class i (nci ctcae 3.0 ) myocardial ischemia, arrhythmia(including qtcf:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency * pregnant or lactating women * before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * urt: urine protein ≥ (++)and \> 1.0 g of 24 h * pt, aptt, tt, fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation * certain possibility of gastric or intestine hemorrhage
spanish registry of erythropoietic stimulating agents study

Conditions: Myelodysplastic Syndrome

Summary: reviewing spanish record of myelodysplastic syndromes (resmd) data base in the group of patients with mds. the information will be collected retrospectively from diagnosis of mds, until the date of december 31, 2011.

review of resmd data base in the group of patients with mds from diagnosis of low risk myelodysplastic syndrome (mds) and occurrence of anemia that began treatment with erythropoiesis stimulating agent (esas) / support transfusional before december 31, 2011. in all cases, data obtained will be prior to the date of the start of the study to ensure its retrospective nature, thus reflecting the routine use of erythropoietic agents in clinical and non-interference in the doctor's clinical practice.

Eligibility criteria:
inclusion criteria: * the patient has given consent to the collection of data in the resmd. * age ≥ 18 years. * patient must be diagnosed with mds according to who classifications or fab low-risk (ipss low and intermediate-1) with anemia (hb ≤ 11 g / dl). * the patient has studies at the time of diagnosis discard the possibility that mds anemia is due to deficiency of factors (iron, vitamin b12 or folic acid). * initiation of treatment with esas or support transfusional at any spanish hematology service before december 31, 2011. exclusion criteria: * pretreatment of smd with hypomethylating agents, lenalidomide, chemotherapy, other.

Keywords: low-risk mds myelodysplastic syndrome retrospective
periprocedural glycemic control in patients undergoing coronary angiography

Conditions: Diabetes Mellitus; Coronary Artery Disease

Summary: there are 24 million people with diabetes mellitus (dm) in the united states. over one-third of patients presenting for coronary angiography have known dm, and an additional 20% of patients without known dm present with hyperglycemia on the day of coronary angiography. hyperglycemia in the setting of urgent and elective percutaneous coronary intervention (pci) is associated with a 40% relative increase in long-term mortality regardless of diabetic status. mechanisms linking periprocedural hyperglycemia to adverse outcomes are poorly understood and the effects of treatment are unknown. this is a pilot study aimed at determining the effectiveness, feasibility and safety of continuing long-acting hypoglycemic medications on the morning of coronary angiography. since hyperglycemia may cause increased platelet reactivity, a secondary aim is to evaluate a possible mechanism of benefit of periprocedural glycemic control on platelet activity. patients with dm on hypoglycemic medications undergoing coronary angiography will be randomized to either continue or hold their clinically-prescribed long-acting hypoglycemic medications on the day of procedure. patients with and without dm will be randomized to either routine care or additional glycemic control with the yale insulin infusion protocol for 6 hours post-pci. the primary endpoint of this study will be mean blood glucose level at the time of arterial access in the hold versus continue groups. secondary endpoints will be mean blood glucose level at 6 hours post-pci in the yale versus routine care groups and number of hypoglycemic events in the glycemic control versus no glycemic control groups. the exploratory analysis assessing the effect of glycemic control on platelet activity will guide further studies evaluating the translation of an individual's platelet phenotype to the clinical risk of increased long-term mortality following pci. the outcomes for this study (glucose levels and platelet function) are all measured during the hospital stay which averages 1 day.


Eligibility criteria:
inclusion criteria: * all patients undergoing coronary angiography at the manhattan campus of the va ny harbor healthcare system exclusion criteria: * 1. patients who do not or are unable to consent. 2. patients participating in a competing study. 3. for platelet substudy, patients who took nsaids within 72 hours of blood collection or who are on cilostazol or dipyridamole as part of their routine medication regimen. 4. patients with any other co-morbidities that would influence subject safety.

Keywords: percutaneous coronary intervention